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False Advertising Food, Drug and Cosmetic Act Off-Label Promotion

House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech

by Hogan Lovells on

The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills...more

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

Public Statements Made by Pharmaceutical and Biotech Company Executives May Raise FDA’s Hackles if They Do Not Meet Basic...

by Mintz Levin on

For players in the highly regulated pharmaceutical and health care industries, it is common knowledge that manufacturers and distributors of FDA-regulated products are required to promote their products in compliance with the...more

Second Circuit Holds Food, Drug and Cosmetic Act Does Not Prohibit Off-Label Promotion

by Dechert LLP on

In a significant blow to the U.S. government’s enforcement efforts against the pharmaceutical industry, a panel of the Second Circuit overturned the conviction of a pharmaceutical sales representative for conspiracy to...more

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